South Australian Meningococcal B Vaccine Herd Immunity Study in Adolescents

• Register: ANZCTR
• Last refreshed on: 26 August 2019
• Main ID: ACTRN12617000079347
• Date of registration: 16/01/2017
• Prospective Registration: Yes
• Primary sponsor: The University of Adelaide
• Public title: South Australian Meningococcal B Vaccine Herd Immunity Study in Adolescents
• Scientific title: A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis in adolescents in South Australia
• Date of first enrolment: 03/04/2017
• Target sample size: 44000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000079347.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Ms Kathryn Riley

• Name: Prof Helen Marshall

Key inclusion & exclusion criteria

Inclusion criteria: 1. South Australian secondary school students in years 10, 11, and 12 in 2017
2. Written parental consent for those under the age of 18
3. Written student consent-assent for those under the age of 18 (or if 18 years old and older consent for themselves)
4. Available at school for at least the first pharyngeal swab

Exclusion criteria: 1. Previous recipient of 4CMenB vaccine (Bexsero)
2. Known pregnancy
3. Anaphylaxis following any component of the 4CMenB vaccine

Age minimum: 14 Years
Age maximum: 100 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Invasive Meningococcal disease;Neisseria meningitides nasopharyngeal carriage;
Invasive Meningococcal disease
Neisseria meningitides nasopharyngeal carriage

Infection - Studies of infection and infectious agents

Public Health - Epidemiology

Intervention(s)

Group A - 2017
Students within schools randomised to group A will receive two doses of 0.5ml of the licensed 4CMenB vaccine administered by intramuscular injection in 2017, with an interval of 1-2 months between doses, as per the Australian Technical Advisory Group on Immunisation recommendations. An oropharyngeal swab will be collected at baseline and at 12 months.

Group B - 2018
Students within schools randomised to group B will receive two doses of 0.5ml of the licensed 4CMenB vaccine administered by intramuscular injection in 2018, with an interval of 1-2 months between doses. Following completion of baseline and 12 month oropharyngeal swab.

Primary Outcome(s)

Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) as measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students. [One year after baseline visit]

Secondary Outcome(s)

Risk factors associated with carriage prevalence of disease causing N. meningitidis at baseline and 12 months. Risk factors were collected using a study-specific questionnaire.[Baseline and 12 months]

Acquisition of all N. meningitidis as measured by PCR in vaccinated and unvaccinated year 10 and 11 school students.[12 months]

Prevalence of all N. meningitidis genogroups as measured by PCR at the 12 month pharyngeal swabs in vaccinated and unvaccinated year 10 and 11 school students [One year after baseline visit]

Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y) as measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 high school students. [One year after baseline visit]

Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup) as measured by PCR in vaccinated and unvaccinated year 10 and 11 school students.[One year after baseline visit]

Risk factors associated with carriage prevalence of all N. meningitidis at baseline and 12 months. Risk factors were collected using a study-specific questionnaire.[baseline and 12 months ]

Secondary ID(s)

ClinicalTrials.gov Identifier: NCT03089086

Source(s) of Monetary Support

GlaxoSmithKline Biologicals S.A.

Ethics review

Status: Approved
Approval date:
Contact:

Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC) Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC) 

Results

• Results available: Yes
• Date Posted: 03/07/2019
• Date Completed: 31/12/2018